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NCT03863574 · ClinicalTrials.gov registry record · Phase 2
Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis
A Phase 2 study of Nonalcoholic Steatohepatitis, sponsored by Zydus Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 6
- Study locations
NCT03863574: Completed Phase 2 study of Nonalcoholic Steatohepatitis, sponsored by Zydus Therapeutics.
NCT03863574 is a Phase 2 study of Nonalcoholic Steatohepatitis that has completed, run by Zydus Therapeutics. The registered enrollment target is 16 participants, below the 702-participant average among 30 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (98% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03863574, a Phase 2 study of Nonalcoholic Steatohepatitis, has completed, sponsored by Zydus Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a randomized, double-blind, placebo-controlled study to evaluate safety and efficacy of Saroglitazar Magnesium 2 mg and 4 mg in patients with NASH. This study will be initiated after obtaining the approvals of Institutional Ethics Committee/Institutional Review Board (IEC/IRB) and the local regulatory authority.
Primary Outcome
The primary endpoint is to assess the changes in NAFLD Activity Score (NAS) at week 24 from baseline and with no worsening of fibrosis in NASH patients. NAFLD Activity Score Steatosis \<5% - 0 5% -33% - 1 \>33% -66% - 2 \>66% - 3 Lobular Inflammation No foci - 0 \<2 foci per 200 X field -1 2-4 foci per 200 X field - 2 \>4 foci per 200 X field - 3 Ballooning None - 0 Few balloon cells -1 Many cells/prominent ballooning - 2 Final NAFLD Activity Score = Steatosis Score + Lobular Inflammation Score
Conditions Studied
Interventions
- DRUG Placebos
- DRUG Saroglitazar Magnesium 2mg
- DRUG Saroglitazar Magnesium 4mg
Study Locations (6)
Tennessee
- Gastro One - Germantown
- Digestive Health Research - Hermitage
Texas
- Texas Liver Institute - San Antonio
- Clinical Trials of Texas, Inc. - San Antonio
Mississippi
- Southern Therapy and Advanced Research (STAR) LLC - Jackson
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-06-12 |
| Est. Completion | 2020-03-20 |
| Phase | Phase 2 |
What the finished NCT03863574 record still lists
NCT03863574 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 702-participant average among 30 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 3 interventions - of which Placebos is the first listed.
NCT03863574 lists 6 locations in 4 states (Tennessee, Texas, Mississippi).
Frequently Asked Questions
What is clinical trial NCT03863574 about?
NCT03863574 is a clinical study titled "Saroglitazar Magnesium in the Treatment of Non-Alcoholic Steatohepatitis". This is a randomized, double-blind, placebo-controlled study to evaluate safety and efficacy of Saroglitazar Magnesium 2 mg and 4 mg in patients with NASH. This study will be initiated after obtaining the approvals of Institutional Ethics Committee/Institutional Review Board (IEC/IRB) and the local ...
What is the current status of trial NCT03863574?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2019-06-12. Estimated completion is 2020-03-20.
What conditions does trial NCT03863574 study?
This clinical trial studies the following conditions: Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT03863574?
The interventions under investigation include: Placebos (DRUG), Saroglitazar Magnesium 2mg (DRUG), Saroglitazar Magnesium 4mg (DRUG).
Who is sponsoring clinical trial NCT03863574?
This trial is sponsored by Zydus Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03863574 being conducted?
This trial has 6 study locations across Mississippi, Tennessee, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03863574's enrollment target sits among peer trials
16 31st of 30 the lowest of 30 other Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
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